Sepha Ltd
Unit 25 Carrowreagh Business Park
Carrowreagh Road, Dundonald
Belfast
BT16 1QQ
Northern Ireland
United Kingdom
Tel: +44 (0)28 9048 4848
Fax: +44 (0)28 9048 0890
Email: info@sepha.com
Contact Us
FAQs about BlisterScan Non-Destructive Leak Tester for Blisters
Q. Will BlisterScan save me money?
A. As well as generating valuable time saving, there are substantial cost savings to be made. Generally a company will save at least $1,000 per day by replacing the Blue Dye Test, which renders all product unusable, with the BlisterScan test. At this value the BlisterScan has a payback in 50 days. For higher value products, the daily savings are in the order of many thousands of dollars and consequently BlisterScan will have a shorter payback period.
Q. How many blisters can we test at once?
A. You can test as many blister packs as will fit on the BlisterScan format (320mm x 150mm). Usually the same number of blisters which are sealed in a single stroke on the blister packing machine are all also tested at the same time. The blisters are usually arranged in the BlisterScan in the same positions as they appear on the sealing plate of the blister packer so that there is immediate correlation.
Q. How long does the test last?
A. On average about 2 minutes. Some packs can be much faster (30 seconds) depending on the size of hole you wish to detect. Unlike the Blue Dye Test you can detect holes as small as 10 micron. To detect a hole this size, the test requires a little longer than the 30 seconds needed to detect a hole of 25 micron or larger.
Q. How long does the changeover take between different blister packs?
A. Changeover lasts about one minute. The only components required are two plates, which slide easily into the machine. Each plate is supplied with its own different identification code, which is automatically read by the BlisterScan to verify that the correct plates are being used for the correct product. As soon as the BlisterScan reads the code it instantly loads from its database a photograph of the packs identical to those to be tested as well as the data used as test criteria for the BlisterScan. The operator only adds the batch number and any other variable information your company considers critical. We can customize the VDU screens to match your corporate procedures.
Q. What does BlisterScan do with the test results?
A. The results are stored in BlisterScan's computer files. Each file is unique to a particular product test and each result is date and time recorded. The results can be printed out to any compatible printer (Hewlett Packard) or copied on to a floppy disk. You can set up layers of authority so that access to critical file management procedures is limited to approved individuals. A full audit trail is maintained.
Q. Is BlisterScan 21 CFR Part 11 compliant?
A. BlisterScan software has been re-written to fully comply with 21 CFR Part 11 and full validation documentation is available.
Q. Is a printer included with BlisterScan?
A. Sepha supply printers as an added option with the BlisterScan or you may wish to supply your own.